ISO 9001 vs ISO 13485

What is ISO 9001?
ISO standards, alongside those issued by the International Electrotechnical Commission (IEC), are globally recognized benchmarks for harmonized practices.
Established in 1947, the International Organization for Standardization (ISO) ensures the safety and quality of products through comprehensive standards covering various aspects such as quality management, measurement standards, corporate reliability, and information security systems.
In medical devices, ISO 13485:2016 stands out as a crucial standard, highlighting requirements for Quality Management Systems (QMS) applicable to manufacturers and service providers in this sector.
Similarly, ISO 9001 outlines general criteria for QMS across industries. That means that 9001 is industry agnostic.
But what sets these standards apart, and when should companies adhere to one over the other, or both?
Here, we delve into the specific disparities between ISO 13485 and ISO 9001.

ISO 9001:

ISO 9001 was first introduced in 1987 and updated most recently in 2015.
It comprises the prerequisites for quality management systems across businesses of all sizes and sectors.
Certification to ISO 9001 demonstrates an organization's ability to consistently deliver products and services that meet both customer expectations and regulatory requirements.
The primary objective of ISO 9001 is to establish processes for documenting and assessing key components of an effective quality management system. This includes defining organizational structures, responsibilities, and procedures.
The standard covers various facets of QMS, including:
General requirements for quality management systems, encompassing documentation and planning.
Management commitment and leadership involvement.
Human resources, work environment, and resource management.
Product lifecycles, from design through to delivery.
Evaluation and enhancement of the quality management system, involving audits and corrective and preventive actions.

ISO 13485 was initially released in 1996 and underwent its latest update in 2016.
While originally rooted in ISO 9001's quality requirements, ISO 13485 has since evolved into a distinct standard that no longer references ISO 9001.
This standard specifically outlines the requirements and protocols for quality management systems within the medical device industry.
A significant aspect of ISO 13485 is achieved through consistent development and manufacturing processes for medical devices, ensuring alignment with relevant regulatory requirements.
Obtaining ISO 13485:2016 certification is crucial for demonstrating the robustness of your QMS, especially if seeking CE marking in the European Union. Moreover, this certification serves as strong evidence of a high-quality QMS across global markets.

One standard vs the other.
Both ISO 9001 and ISO 13485 adhere to quality management requirements, but what sets them apart?
ISO 13485 is tailored specifically for the medical device industry and introduces unique elements such as medical device terminology, requirements for clinical and performance evaluations, procedures for gathering customer feedback, and detailed records of corrective and preventive actions.

It’s important to note
ISO 9001 is not suitable for demonstrating QMS compliance in the medical device industry. It is designed for organizations outside this sector seeking to validate their QMS across various industries.

Choosing the right QMS standard is pivotal for ensuring employee well-being, product safety, and performance. For medical device manufacturers, ISO 13485 is non-negotiable, while ISO 9001 remains relevant for other industries seeking to enhance QMS credibility.

While certification often serves regulatory and marketing purposes, the inherent value lies in establishing a robust QMS that enhances product quality, employee satisfaction, and, in the case of ISO 13485, patient safety through rigorous risk management practices.

ISO 9001 Article: [ Ссылка ]
ISO 13485 Article: [ Ссылка ]
ISO 9001 vs ISO 13485 Article: [ Ссылка ]

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